AMLEXHALENCT07826897
Real-Time Breath Analysis in Acute Myeloid Leukaemia for a Rapid Characterisation of Biological Subtypes and to Predict Therapy Responses
An observational study of AML, run by Jeremy Deuel at 1 site in Switzerland.
Trial summary
Patients with acute myeloid leukaemia (AML) respond to treatment to differing degrees, owing to the biological diversity of the disease. The diagnostic tests currently available for identifying genetic alterations and selecting the best possible treatment usually take several days before a result is obtained. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Sep 2026to 31 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 AML patients and 20 autologous-transplant controls
Who may be able to join
- Diagnosis of an acute myeloid leukaemia and undergoing treatment
- OR undergoing autoHSCT for lymphoid/myeloma disease in remission
Who cannot join
- inability to perform brath analysis
- anatomical barriers preventing use of the mouthpiece.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Hospital of Zurich
Zurich, Canton of Zurich, 8091
Jeremy W Deuel, PD MD PhD, +41 41 255 11 11, haematologie-onkologie@usz.ch
Kevin D Hofer, MD, +41 41 255 11 11, haematologie-onkologie@usz.ch
About this study
Official title: Exhalomics for Phenotyping and Real-Time Stratification in Acute Myeloid Leukaemia (EXHALE)
Patients with acute myeloid leukaemia (AML) respond to treatment to differing degrees, owing to the biological diversity of the disease. The diagnostic tests currently available for identifying genetic alterations and selecting the best possible treatment usually take several days before a result is obtained. In our study, the investigators aim to determine whether breath analysis can detect metabolic products of the leukaemia that allow the disease to be classified rapidly.
Participants will undergo additional blood tests and a breath analysis during their routine appointments. This will take place only during the 1st and 2nd treatment cycles. They will also be asked to complete a questionnaire about their state of health. In addition, the study team will collect further information on their state of health (type of leukaemia, type of treatment, other medications, vital signs) from their medical records.
In total, participants will complete 4 such measurements before and during their treatment. The measurements will be coordinated with their outpatient appointments. No assessments will be carried out unless the participants are at the hospital in any case, and they will not have to attend the hospital more often because of their participation in this study.
- Conditions
- AML
- Keywords
- Exhalomics, Breath Analysis, AML, Biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AML | Patient with the Diagnosis (initial or relapsed/refractory) of AML | |
| Negative Controls | Patients undergoing high-dose Chemotherapy with autologous stem cell support (autoHSCT) due to lymphoma or myeloma in remission |
What is being measured
The primary outcome is the main question the study is designed to answer.
A breath metabolite signature representing AML disease burden
A breath metabolite signature representing AML disease burden, and might represent novel AML subtypes or describe cancer metabolic status.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeremy Deuel
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich, ETH Zurich
- Responsible party
- Sponsor-investigator, Jeremy Deuel, University of Zurich
- Investigators
- Jeremy W Deuel, PD MD PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826897
- Sponsor's protocol ID
- HumRes68544
- Other IDs
- SNCTP000007074, BASEC2026-00409, HumRes68544
- Acronym
- EXHALE
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Mass Spectrometry Raw Data of Study Participants will be made available on an appropriate platform.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhalomics for Phenotyping and Real-Time Stratification in Acute Myeloid Leukaemia (EXHALE)
- ClinicalTrials.gov ID
- NCT07826897
- Acronym / sponsor ID
- EXHALE / HumRes68544
- Conditions
- AML
- Keywords
- Exhalomics, Breath Analysis, AML, Biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jeremy DeuelUniversity, hospital or other
- Collaborators
- University Hospital, Zürich, ETH Zurich
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with acute myeloid leukaemia (AML) respond to treatment to differing degrees, owing to the biological diversity of the disease. The diagnostic tests currently available for identifying genetic alterations and selecting the best possible treatment usually take several days before a result is obtained. In our study, the investigators aim to determine whether breath analysis can detect metabolic products of the leukaemia that allow the disease to be classified rapidly.
Participants will undergo additional blood tests and a breath analysis during their routine appointments. This will take place only during the 1st and 2nd treatment cycles. They will also be asked to complete a questionnaire about their state of health. In addition, the study team will collect further information on their state of health (type of leukaemia, type of treatment, other medications, vital signs) from their medical records.
In total, participants will complete 4 such measurements before and during their treatment. The measurements will be coordinated with their outpatient appointments. No assessments will be carried out unless the participants are at the hospital in any case, and they will not have to attend the hospital more often because of their participation in this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AML | – | –Patient with the Diagnosis (initial or relapsed/refractory) of AML |
| Negative Controls | – | –Patients undergoing high-dose Chemotherapy with autologous stem cell support (autoHSCT) due to lymphoma or myeloma in remission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 AML patients and 20 autologous-transplant controls
Key inclusion criteria (2 listed)
- Diagnosis of an acute myeloid leukaemia and undergoing treatment
- OR undergoing autoHSCT for lymphoid/myeloma disease in remission
Key exclusion criteria (2 listed)
- inability to perform brath analysis
- anatomical barriers preventing use of the mouthpiece.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A breath metabolite signature representing AML disease burden
Time frame: 8 weeks
A breath metabolite signature representing AML disease burden, and might represent novel AML subtypes or describe cancer metabolic status.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. Mass Spectrometry Raw Data of Study Participants will be made available on an appropriate platform.
Related trials for AML
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AML (Acute Myeloid Leukemia)
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R/R AML, R/R HR-MDS
RecruitingPhase 2
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Not yet recruitingPhase 1
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeremy W Deuel, PD MD PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AML, run by Jeremy Deuel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeremy W Deuel, PD MD PhD (+41 41 255 11 11, haematologie-onkologie@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A breath metabolite signature representing AML disease burden (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.